This medicine is authorised for use in the European Union.


Pifeltro is an antiviral medicine used to treat adults and adolescents from 12 years of age weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Pifeltro is used together with other antiviral medicines.

It is only used in patients where the virus has not developed resistance to medicines that work in the same way as Pifeltro.

Pifeltro contains the active substance doravirine.

This EPAR was last updated on 20/02/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

10/10/2022 Pifeltro - EMEA/H/C/004747 - IG1535

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.

Assessment history

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